AHRQ invites applications to develop a prospective clinical registry of orthopedic devices, drugs,
and procedures through a practice-based research collaborative and clinical and
outcomes data resource (P50 grant mechanism). The
goal of this registry initiative is to support the development of a sustainable
data infrastructure and to conduct rigorous clinical and scientific research
including comparative effectiveness and safety research. AHRQ envisions
utilizing a practice based orthopedic registry across a broad provider network
as one of the potentially most effective and productive approaches to develop
scientific evidence regarding the short and long term benefits and harms of
implantable orthopedic devices and other related services. The registry will be
a model and basis for other national device and procedure registries and will
actively disseminate study results into clinical practice.

The Medicare Prescription Drug,
Improvement, and Modernization Act (MMA) Section 1013 (42 USC 299b-7)(see http://effectivehealthcare.ahrq.gov/)
authorized AHRQ to develop a program of comparative effectiveness research,
thus, establishing the Effective Health Care (EHC) Program. To help
achieve the objectives of the EHC program, AHRQ will provide support to develop
and maintain the infrastructure of a multi-center orthopedic registry and the
conduct of multiple collaborative, prospective multi-center studies of
orthopedic devices and procedures. The capacity to include community-based
smaller practice sites, in addition to high volume institutions, as
participants in the registry is strongly encouraged.

One
awardwill be made for the development of the
prospective clinical registry
of orthopedic devices, drugs, and procedures. The initial focus of the registry
effort will be to develop the necessary infrastructure for data collection and
comparative effectiveness research activities with concentration
on hip and knee replacements. The applicant is expected to form
the core of the registry; a Research and Data Coordinating Center
(RDCC) functioning through the guidance of the Registry Steering Committee
(RSC) (see “Other Special Eligibility Criteria” for additional
details). The applicant is also expected to develop the
infrastructure including at least five
Clinical Centers (CC) at institutions performing high volume of hip and knee
replacements.

The goal of the FOA is to generate and advance the scientific knowledge of hip
and knee replacement procedures and orthopedic devices. The registry shall
serve to enable the conduct of studies focusing on comparative effectiveness
and safety of various orthopedic procedures and devices and could also ideally
serve as a resource for quality improvement initiatives.

The data collection efforts funded by this FOA should be ideally designed in a
way to take advantage of and advance in scientific, technical, and operational
terms existing local clinical and patient outcomes data collection effort
and/or registries.

The newly developed registry will also provide the infrastructure to conduct
multi-center collaborative clinical studies to address effectiveness and
patient outcomes questions as well as emerging public health issues related to
orthopedic procedures and devices. A minimum of 3 core research studies are
to be included in the grant application for the orthopedic registry under the
P50 Specialized Center mechanism.

Funds Available and
Anticipated Number of Awards: AHRQ intends to commit up to
$3,000,000 total costs in FY 2010 to fund one application that will include a
RDCC to build an infrastructure that involves at least five separate clinical
centers (systems). AHRQ plans to award a
total amount of up to $12,000,000 (total costs) over four years. The total amount awarded will depend upon the
quality, duration, and proposed research projects of the applications
received. Applications
may be up to four years in duration not to exceed $3,000,000 per year in total costs to the government.
Applications with project periods that exceed four years or budgets that exceed
$12,000,000 total costs will not be reviewed.

The award issued under this FOA is contingent upon the
availability of funds and the submission of meritorious applications.

Budget and Project Period:The total costs awarded under this FOA will not exceed
$3,000,000 annually in any given year of a four year project. An
application with a budget that exceeds $3,000,000 total costs per year or four years
in duration will not be reviewed. Funding beyond the first year will be
contingent upon a review and acceptance by Agency staff of the progress report.

Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to work with their institution/organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups
as well as individuals with disabilities are always encouraged to apply for
AHRQ support.

Number of PDs/PIs:
Only one PD/PI may be designated on the application.

Number
of Applications:Applicants may submit more than one
application, provided each application is scientifically distinct.

Resubmissions:
Resubmission
applications are not permitted in response to this FOA.

Renewals: Renewal applications are not permitted in response to this
FOA

Hearing Impaired:Telecommunications
for the hearing impaired are available at: TTY 301-451-5936.

While
AHRQ grant awards are made to institutions rather than individuals, this
announcement and its instructions are written to inform individual researchers
of this funding opportunity and facilitate the submission of grant applications
by their organizations.

The purpose of this FOA is to develop a large multi-center, preferably
national orthopedic registry and conduct rigorous clinical and scientific
research with a primary focus on comparative effectiveness and safety research
and to develop scientific evidence regarding the short and long term benefits
and harms of implantable orthopedic devices, drugs, and procedures.

AHRQ will provide support to develop the
infrastructure of a multi-center orthopedic registry and the conduct of
multiple collaborative, prospective multi-center studies. The development of a large scale
practice-based orthopedic registry is intended not only as a resource for
affirming the findings of existing population-based studies but also to advance
new knowledge and to conduct new innovative comparative effectiveness research.
Prospective multi-center clinical studies conducted utilizing the registry will
help elucidate the benefits and harms of therapeutics, in particular benefits
and harms of implantable orthopedic medical devices and procedures. Further, the
registry-based studies will enable and facilitate the inclusion of
traditionally understudied subpopulations with inherent vulnerabilities,
disparities, or risks of serious outcomes. Improved evidence on comparative
clinical effectiveness will inform decisions made by patients, clinicians,
payers, and regulators.

In 2003, the Medicare Prescription Drug, Improvement,
and Modernization Act (MMA) was enacted into law. Section 1013 of MMA
authorized AHRQ to conduct research, demonstrations, and evaluations designed
to improve the quality, effectiveness, and efficiency of Medicare, Medicaid,
and the State Children's Health Insurance Program (SCHIP),
thus, establishing the Effective Healthcare Program (EHC) Program (http://effectivehealthcare.ahrq.gov/ ) at AHRQ.

The
EHC program focuses on evidence of the relative benefits and risks of
alternative interventions. It does not make treatment or coverage
recommendations. Consumers, clinicians, payers, and others can make decisions
and select treatments that reflect their own unique needs and values in the
context of these effectiveness findings. The program is intended to help build
research capacity and provide for support that is specifically intended to fill
priority research gaps informed by stakeholders and users.

Americans undergo more than 700,000 hip and knee replacements
annually. There are thousands of devices and device combinations in use to
perform hip and knee replacement and repair procedures. The comparative
effectiveness of these devices is unknown. It is impractical to study
comparative effectiveness of these devices and procedures in randomized
clinical trials given the enormous number of comparisons and sample sizes
necessary to reach valid conclusions. Moreover, randomized clinical trials have
a number of limitations that are hard to overcome in the area of comparative
effectiveness of devices and less invasive surgery.

Many new devices and procedures are initially advocated by
surgeon enthusiasts of the particular device/procedure who are some of the best
performing surgeons. Real world performance of these devices is less clear when
the technology is rapidly diffused into practice. An Orthopedic registry that
captures real world experience with these devices and procedures would be a
valuable resource to inform decision makers (patients, physicians, hospitals
and policy makers) about comparative effectiveness and will ultimately serve to
improve patient outcomes, quality of care, and safety.

Research studies proposed as part of developing the registry
must be designed as multi-center initiatives and serve to guide infrastructure
development. The studies must have a high impact, be implemented in practice,
and have a substantial capacity to inform decision-making that improves patient
outcomes and public health. The studies must be set up to address questions
that are of great public health and patient outcomes concerns that are viable
only with the support of public funding. Studies must be powered to
address clinically important endpoints and must also be able to study
comparative effectiveness and safety across demographic and clinical
subpopulations. A minimum of 3 core research studies are to be included
in this registry application.

Below are
examples of core research studies that are responsive to research plan
requirements of this FOA. These include, but are not limited to, those
described below:

Conduct
a study using prospectively collected clinical and patient reported data
and identify clinical (i.e. extent and location of lesion, type of
implant, single joint vs both joint replacement need), demographic
(age, gender, race and ethnicity), comorbidities (diabetes, renal failure)
as well as institutional (hospital size, urban vs rural, teaching vs
non-teaching), social, economic and other factors associated with the long
term functioning, quality of life and other patient reported outcomes of
various hip and knee replacements/implants.

Design
and execute a large and representative observational study to determine if
age, gender and race are associated with higher occurrence of mortality,
repeat surgery or other outcomes. Discuss the importance of
confounding, effect modification and other issues of internal validity and
external validity/generalizibility issues.

Study
determinants of joint replacement failure in large clinical database study
and report the best methodological approaches to the assessment of joint
replacement failure. Report consequences of failure in terms of
functioning, quality of life, and long term disability.

Study
of allergies or other sensitivity to the components of the artificial
joints.

The proposed
research projects must start with a critique and synthesis of available data
and the medical literature and critically evaluate the evidence and the
outstanding research, and identify public health questions that are uncertain
or unanswered. Based on the critique, the application must describe an
approach to address identified questions. The proposed approach must specify
the analytic design, statistical power, and feasibility of addressing the
unanswered questions.

This
Funding Opportunity Announcement (FOA) will use the P50 (specialized center)
award mechanism. The individual researcher sponsored by the
organizational grantee will be solely responsible for planning, directing, and
executing his or her proposed projects.

2.
Funds Available

AHRQ
intends to commit up to $3,000,000 total costs in FY 2010 to fund one
application that will include a RDCC to build an infrastructure that involves
at least five separate clinical centers (systems).
AHRQ plans to award a total amount of up to $12,000,000 (total costs) over four
years. The total amount awarded will depend
upon the quality, duration, and proposed research projects of the applications
received. The award issued under this FOA is contingent upon the availability
of funds and the submission of meritorious applications. Applications may be up to four years in duration
not to exceed $3,000,000 per year in
total costs to the government. Applications with project periods that
exceed four years or budgets that exceed $3,000,000 total costs in any given
year will not be reviewed.

Although the
financial plans of AHRQ provide support for this program, awards pursuant to
this funding opportunity are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications. Facilities
and administrative (F&A) costs requested by applicants are included in the
total cost limitation.

Section III. Eligibility Information

1.
Eligible Applicants

1.A. Eligible
Institutions

You may
submit an application(s) if your domestic institution/organization has any of
the following characteristics:

Public or non-profit private institution, such as a
university, college, or a faith-based or community-based organization;

Units of local or State government;

Eligible agencies of the Federal government.

Indian/Native American Tribal Government (Federally
Recognized);

Indian/Native American Tribal Government (Other than
Federally Recognized);

Indian/Native American Tribally Designated Organizations.

AHRQ’s authorizing legislation does not allow
for-profit organizations to be eligible to lead applications under this
research mechanism, thus for the purpose of this FOA, AHRQ will make grants
only to non-profit organizations. For-profit organizations may
participate in projects as members of consortia or as subcontractors
only. Because the purpose of this program is to improve healthcare in the
United States, foreign institutions may participate in projects as members of
consortia or as subcontractors only. Applications submitted by for-profit
organizations or foreign institutions will be returned without review.
Organizations described in section 501(c) 4 of the Internal Revenue Code that
engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the PD/PI is invited to work
with his/her organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for AHRQ support (see Other-Special
Eligibility Criteria for additional requirements).

A minimum time commitment of 40%
annual effort is expected from the Principal Investigator and a minimum of 25%
annual effort is expected from the Lead Co-Investigator at each CC.

2.
Cost Sharing or Matching

This program
does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes
applicant institutions, including any collaborating institutions, to devote
resources to this effort. An indication of institutional support from the
applicant and its collaborators indicates a greater potential of success and
sustainability of the project. Examples of institutional support would include:
donated equipment and space, institutional funded staff time and effort, or
other resource investments. Applicant institutions should indicateinstitutional
support by outlining the specific contributions to the project and providing
assurances that their organization and any collaborators are committed to
providing these funds and resources to the project. This can be included
at the end of the budget justification section of the application, but
institutional support dollars are not to be shown/included in the detailed
budget request.

3.
Other-Special Eligibility Criteria

The PD/PI for applications responding to
this FOA will need to act as the Lead for
the Research and Data Coordinating Center (RDCC) and build the registry
including at least five Clinical Centers/Systems (CC) as well as establish
governance through a National Steering Committee. To inform the registry development
activities, the PD/PI must hold preliminary discussions with relevant
orthopedic specialty societies and other important stakeholders regarding any
on-going data standardization and transmission effort and coordinate with all
participating clinical centers on the harmonization of such protocols.

The application must
describe the plan of collaborative work between the RDCC and the participating
CCs, as well as include a description of how the projects fits with the AHRQ
Effective Health Care program. The grantee must report semi-annually on patient
recruitment and study progress. The PD/PI will ensure disclosure of conflicts
of interest. Upon award, the PD/PI, in consultation with AHRQ, will appoint the
Registry Steering Committee Chair and members of the Registry Steering
Committee and Subcommittees, which will include not only registry studies
investigators but other relevant stakeholders. An AHRQ Program Official
will also serve as ex-officio member of the Steering Committee. The
Registry Steering Committee should also include representatives from the Center
for Medicare and Medicaid Services (CMS) and the Food and Drug Administration
(FDA) as ex-officio members, as well as a patient representative. All
ex-officio members are non-voting, and the PD/PI will have the final approval
for all committee appointments. The Registry Steering Committee chair
shall be a well regarded researcher and shall not have substantial financial
conflict of interest.

The PD/PI must propose three core studies addressing topics related to
comparative effectiveness that will be conducted in the multicenter environment
within a 4 year time frame. The three core research studies must be agreed by
all clinical centers that will be participating in the registry. The proposed
studies must demonstrate detailed knowledge of the conduct of multi-center
clinical studies, involve large number and broad spectrum of patient
populations (including racial and ethnic minority populations) and require
multicenter participation. The
PD/PI, in collaboration with CCs, will ensure proposals adherence, accurate and
timely transmission of collected data and dissemination of research
findings. A minimum time commitment of 40% annual effort is expected from
the PD/PI, and 25% annual effort is expected from the lead Co-Investigator at
each CC.

The Registry Steering
Committee (RSC)

The registry will have a RSC as the
governing body of the registry development. Voting members of the RSC
include, at a minimum, the Chair and lead co-investigators for CCs. The
chair will advise the PD/PI (RDCC) on research activities and functions, and
conduct SC meetings. The RDCC will support the RSC to ensure compliance with
registry policies/procedures and will have a data safety and monitoring plan.

The RDCC will also support
the RSC in identifying and prioritizing topics for investigation and evaluate
secondary proposals developed by participating physician-researchers. The RSC
will ensure that study results are reported in the scientific literature in a
timely manner and promptly disseminated to those directly involved in the care
of patients.

Funds must be budgeted to
hold RSC meetings as often as three times in the first 12 months of the
registry development, two to four times per year thereafter, and by
teleconference on a monthly basis throughout the project period.

It is anticipated that the
registry will be a great resource for conducting numerous non-AHRQ supported
secondary research studies in addition to three core large scope study
proposals outlined in the application. The RSC will be responsible for
approving these leveraged secondary proposals submitted by participating
researchers. Prior to being forwarded to the steering committee,
secondary proposals will be evaluated by the Publication and Proposal Review
Subcommittee (see section IV, 6).

Applicant
institutions may submit more than one application in response to this FOA,
provided each application is scientifically distinct. However, AHRQ will
not accept similar grant applications with essentially the same research focus
from the same applicant organization.

Applications must include a data safety
and monitoring plan. There must be a system for the appropriate
oversight and monitoring of the conduct of research to ensure the safety of
participants and the validity and integrity of the data for all AHRQ-conducted
or supported research. The method and degree of monitoring must be
commensurate with the degree of risk involved for participating subjects and
the size and complexity of the research. Applications that do not
include a data and safety monitoring plan will not undergo peer review or
consideration for funding.

Data
and safety monitoring plans are required in all research grant applications
when support is sought to study the effect of a health-related intervention on
outcomes in human subjects, including biomedical, behavioral, public health,
health care system, and/or diagnostic interventions that potentially affect the
outcome of the study participants. Data and safety monitoring involving
some level of independent monitoring, generally in the form of a Data and
Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC), is required
for research studies involving: interventions that entail potential risk
to research participants, multiple sites, blinded (masked) designs, or
vulnerable populations (e.g., children, pregnant women, frail elderly).

Applicants are not permitted to submit a resubmission
application in response to this FOA.Renewal applications are
not permitted in response to this FOA.

Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site athttp://www.dnb.com/us/. The D&B number must be entered on line 11 of the face
page of the PHS 398 form.

The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked. 3.
Submission Dates and Times

To allow AHRQ staff to estimate
the potential peer review workload and plan the review (e.g., anticipate the
nature of reviewer expertise to be required), prospective applicants may submit
a letter of intent that includes an acknowledgement of interest in this funding
opportunity (please refer to the number and title of this funding opportunity),
a few comments on the subject of the proposed research, background expertise of
key personnel, and the nature and role of participating institutions.
Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding,
and is not considered in the review of a subsequent application. However,
these letters are administratively very helpful, as indicated above. To be
most useful, the letter of intent is to be sent by the date listed in Section
IV.3.A.

The letter of intent can be sent electronically, and
should be sent to:

AHRQ encourages applicants to take advantage of a technical
assistance conference call sponsored by AHRQ program staff. The purpose
of the conference call is to provide potential applicants with background
information and respond to questions about the preparation of an application in
response to this FOA. The conference call will take place on August 17,
2009 from 1:00 – 2:00 pm Eastern daylight time. To register to
participate in the conference call, please send an e-mail request to OrthopedicRegistry@ahrq.hhs.gov by August 10, 2009. Once a registration email has been submitted, an
email reply will be sent within 2 business days containing information on the
call, including call-in information. Potential applicants are encouraged
to contact AHRQ staff with any questions (see Section VII, Agency Contacts,
below).

The conference call is open to any individual or
organization intending to apply. Participation is not a prerequisite to
applying. Participants are encouraged to submit questions via email prior
to the conference call. Please submit up to five questions with your name
and the name of your institution to OrthopedicRegistry@ahrq.hhs.gov by August 10, 2009. Questions of a similar topic and nature may be
grouped at the sole discretion of AHRQ staff. Notes from the conference
call will be posted on the AHRQ web site.

3.B.
Sending an Application to AHRQ/NIH

Applications must be prepared using the forms found in
the PHS 398 instructions for preparing a research grant application. Submit a
signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Applications must be received
on or before the application receipt date stated above (Section IV.3.A.). If an application is received after that date, the
application may be delayed in the review process or not reviewed. Upon
receipt, applications will be evaluated for completeness by the CSR, NIH, and AHRQ.
Incomplete and/or non-responsive applications will not be reviewed.

AHRQ will not accept any application in response to this
funding opportunity that is essentially the same as one currently pending
initial merit review, unless the applicant withdraws the pending application.

Although there is no immediate acknowledgement of the
receipt of an application, applicants are generally notified of the review and
funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services
(CMS) public-use data, if required, should be discussed in the application
narrative and included in the budget. Projects will ordinarily not use CMS
(Medicare or Medicaid) data involving individual identifiers. However, for
applications that propose to use Medicare or Medicaid data that are
individually identifiable, applicants should state explicitly in the
“Research Design and Methods” section of the Research Plan (form
398) the specific files, time periods, and cohorts proposed for the research.
In consultation with CMS, AHRQ will use this information to develop a
cost estimate for obtaining the data. This estimate will be included in
the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable
Medicare and Medicaid data, Principal Investigators and their grantee
institutions will be required to enter into a Data Use Agreement (DUA) with CMS
to protect the confidentiality of data in accordance with the confidentiality
provision in the AHRQ statute, 42 USC 299c-3(c); the Privacy rules at 45 CFR
Parts 160 and 164, if applicable; and standards set out in OMB Circular A-130,
Appendix III–Security of Federal Automated Information Systems. The use
of the data will be restricted to the purposes and time period specified in the
DUA. At the end of this time period, the grantee will be required to return the
data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional
arrangements, the DUA will include the requirement that the data user agrees to
submit to CMS, a copy of all findings within 30 days of making such findings,
for the sole purpose of assuring CMS that data confidentiality is maintained.
The user further agrees not to submit these findings to any third party
(including but not limited to any manuscript to be submitted for publication)
until receiving CMS's approval to do so.

In developing research plans, applicants should allow
time for refining, obtaining approval, and processing of their CMS data
requests. Requests may take six months from the time they are submitted to
complete. Applications proposing to contact beneficiaries or their providers
require the approval of the CMS Director and may require meeting(s) with CMS
staff.

CMS data are provided on IBM mainframe tapes using the
record and data formats commonly employed on these computers. Applicants should
either have the capability to process these tapes and formats or plan to make
arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the
AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include
the cost of identifiable CMS data in the budget. In the event the total
costs of the project plus the cost of CMS data is greater than the total cost
cap of this FOA, the budget for the project will be adjusted so that the total
costs awarded to the recipient plus the CMS data costs do not exceed the cost
cap.

For efficient grant administration, AHRQ grant
administration procedures will be used and conducted in accordance with the
terms and conditions, cost principles, and other considerations described in
the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A
grantee may, at its own risk and without AHRQ prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs are necessary to conduct the
project and would be allowable under the grant, if awarded, without AHRQ prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain AHRQ approval before incurring the cost. AHRQ prior
approval is required for any costs to be incurred more than 90 days before the
beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.

6. Other
Submission Requirements

The awardee will participate in site visits as needed,
to be conducted by the AHRQ program official. Site visits, which
would generally be expected to occur on an annual basis, are conducted to
review project progress at all participating centers and the level of
institutional support and commitment.

The PD/PI and at least one other project member must
participate in one annual meeting sponsored or supported by AHRQ and need
to budget accordingly.

The applicant may not use more than 15% of the total
federal grant funds to purchase equipment, hardware or software.

The applicant must describe plans to involve significant
stakeholders such as FDA, CMS, other payers, professional societies, and
patient groups in the process of registry development.

PD/PI Responsibilities

A
minimum time commitment of 40% annually is required from the PD/PI. The PD/PI
is expected to be readily available to respond directly to questions about
registry matters. The PD/PI must have a demonstrated track record of successful
leadership of a multi-disciplinary team, including multi-center clinical
collaboration. The PD/PI must be the lead for RDCC and the application
must provide strong evidence of commitment of CCs to support the development of
the registry and conduct collaborative research with the applicant organization
and other participating centers. Letters of institutional and
departmental support for participation in the registry are required, which must
include assurances that in the case of studies competing for the same patient
population, the AHRQ registry initiative will take priority.

The
PD/PI of the application must discuss various aspects of study design that
would be important in developing clinical proposals including eligibility,
sample size and power calculations; methods and frequency of data collection,
monitoring accuracy of data collection, quality control including training and
certification for multiple proposals. Further, the PD/PI must describe RDCC
plans for administrative management of the data collection and quality control,
support of the Registry Steering Committee (RSC), and associated subcommittees.
A plan must also be included for the development and maintenance of a web site
with both public and secure components that would include information for
investigators.

Within
three months after the award, the PD/PI as lead for RDCC, will be required to
organize the first meeting of Registry Steering Committee where Chair, voting,
non-voting members of steering committee and stakeholder representatives will
be elected/ approved. RDCC will also perform all necessary work to establish
central IRB (whenever possible) to facilitate conduct of studies.

The PD/PI must establish a Publications and Proposal Review
Subcommittee (PPRS): of the steering committee. The subcommittee will consist
of a chair and clinicians and scientists with broad range of expertise relevant
to the proposed studies. The
PPRS will evaluate leveraged secondary study proposals (beyond the three core
proposals) under review by the RSC based on the importance of the question to
be addressed, scientific merit of the experimental design and approach,
feasibility, appropriateness for the registry and consistency with comparative
effectiveness. The PPRS will provide a written critique of each proposal
and a final recommendation to the Registry Steering Committee. All study
proposals performed by the registry investigators must be recommended by the
PPRS and approved by the Registry Steering Committee before initiation. It is
anticipated that more than one proposal will be active at any given time.
The Publications and Presentations Subcommittee
will facilitate and work with RDCC in preparation of manuscripts prior to
submission for publication.

The PD/PI and co-investigators
involved in the registry may find it advantageous to seek additional support
from or other involvement by industry or other third parties (e.g., the VA,
CMS, charitable foundations) for the studies themselves or for leveraged
studies. Accordingly, the PD/PI must establish Public Private Partnership
subcommittee of the
Steering Committee that will be responsible for approval of all partner
involvements.

The
application must describe how the 3 core proposed research projects will
provide new information and important information that is distinct from
existing studies and how the study extends what is already known.

The
application must explain how the proposed research projects will provide
actionable information that meets the Effective Health Care program goals in
comparative effectiveness. Specifically, what are the potential impacts
of the findings from the proposed research and how will these findings relate
to specific knowledge gaps relevant to improving the health care delivered
through the Medicare, Medicaid, or the State Children's Health Insurance
(SCHIP) programs.

The
application must highlight specifics of the unique data that can be included in
the registry through primary data collection and describe how the collection of
certain patient reported outcomes not otherwise available will be done. Special
attention must be given to the rigor and efficiency of the data collection and
management systems, protocols for data confidentiality and the governance for
data use and sharing.

Clinical Centers (CC) Participating in the Registry

The application must describe the critical responsibilities of CCs in
recruitment of patients and data collection. It is expected that
individual CCs will vary in nature and experience, and thus may represent both
different patient populations and unique expertise. For example, the CCs could
be geographically diverse major medical centers with existing relationships
with private or community hospitals and physician practices. The lead
co-investigator at each CC must demonstrate clinical research excellence and a
proven ability to recruit patients from various racial/ethnic groups. As a
whole, the registry will enroll eligible patients and assess clinical
interventions on a broad range of diagnostics and therapeutics.

The
application must include detailed sections on the applicant’s clinical
and data resources and capabilities. The application must include at least five
(5) CCs each with sufficient patients to support recruitment in a variety of
studies in the registry. For each CC the application must provide a detailed description of the clinical and
data collection/management capabilities. Below are some of the specific and
desired critical data that can help to address important comparative
effectiveness questions:

Patient
characteristics (demographic variables such as age, race, ethnicity, sex,
medical history and co-morbid conditions such as diabetes, renal
insufficiency)

Substantial
number of people in important subgroups (elderly, women, diabetes,
multiple comorbidities, etc)

Information
and plan to identify all implants (not just names but strategies like
barcode scanning and others)

Medication
and rehabilitation therapy (aggressive pain management, medication use and
how drug use or drug exposure is measured in the long term

Genetic
markers

Long term
activity, functioning and quality of life measures to address specific
study questions (not necessary for every person)

The
application must discuss the agreements and operational arrangements between
CCs to define all data elements, definitions, collection, transmission
protocols, etc., across all registry participants. It must also
describe the timeliness, ownership, signed usage agreements, and governance on
use of data contained in the registry. Specifically, across all CCs where local
data collection and databases will be used to develop the registry, concrete
plans for the following issues must be included in the application:

1.Willingness of
data owners to collect the core set of data elements

2.How data can be
shared (centralized collection and study by study basis)

3.Data access and
ownership

4.Data Use
Agreements or Memos of Understanding

5.Restrictions on
using the data

6.Medical device and
procedure coding and diagnostic information

7.Short and long
term health outcomes collection plans

Budget Information

AHRQ intends to commit up
to $3,000,000 total costs in FY 2010 to fund one application that will include
a RDCC to build an infrastructure that involves at least five separate clinical
centers (systems). AHRQ
plans to award a total amount of up to $12,000,000 (total costs) over four
years. The
applicant must submit a composite budget for the overall registry and
individual budgets and budget justifications for the RDCC and each of the three
research projects. The individual budgets, totaled together, must equal
the composite budget. The budget must include, at a minimum:

1.A
minimum of 40% effort annually for the PD/PI.

2.Steering
Committee expenses. The Steering Committee meets an average of three times a
year and conducts biweekly conference calls and monthly subcommittee calls for
each active proposal based study subcommittee.

3.Visits
to each CC for training and data audit during the four-year grant period.
Audits could occur as frequently as once per year for each CC during the life
of the grant.

4.Monthly
Conference call expenses.

5.Expenses
associated with data collection form development. Instituting quality control
measures will be included in the Research and Data Coordinating Center budget.

6.Expenses
associated with training the Nurse Coordinators at the beginning of each study
if necessary.

7.Expenses
associated with travel for the PD/PI and at least one other project member to
participate in one annual meeting sponsored or supported by AHRQ.

8.Other
research expenses as appropriate.

Applications
must identify the potential source(s) for any drugs, substances, or devices
that are being considered for the proposed clinical studies that are currently
unavailable commercially.

The
funds allocated to CC must include only core costs and must not include
research participation costs. Core budget costs allocated to CC may include but
are not limited to the following:

A minimum of 25% effort annually
for the lead co-investigator of each CC.

A minimum of 100% effort for
nurse(s) or research coordinator(s) (e.g., minimum of one full time
equivalent).

Necessary supplies and
equipment.

Fees for translation of materials
into a second language, if appropriate

Screening of
patients to determine study eligibility.

Imaging
studies that are not performed as part of routine clinical care.

Laboratory
tests that are not part of routine clinical care.

Clinic visits that are not part
of routine clinical care.

Specialized consultation to
perform standardized testing.

Expenses
associated with administration of follow up questionnaires for long term
studies.

Research Plan Page Limitations

The research plan must be limited to 25
double spaced pages with font size 11 or greater.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CD
only, and include five identical CDs in the same package with the application.

Do not use the Appendix to
circumvent the page limitations of the Research Plan component. An application
that does not observe the required page limitations may be delayed in the
review process.

Priority Populations

The Healthcare Research and Quality Act of 1999, in
amending the Public Health Service Act, directed AHRQ, in carrying out its
mission, to conduct and support research and evaluations, and to support
demonstration projects, with respect to the delivery of health care in
inner-city and rural areas (including frontier areas), and health care for
priority populations. Priority populations include low income groups;
minority groups; women; children; the elderly; and individuals with special
health care needs, including individuals with disabilities and individuals who
need chronic care or end-of-life health care. This authority is found at
42 USC 299(c). To implement this statutory mandate, AHRQ published a
Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy
on the Inclusion of Priority Populations in health services research (see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the
results of AHRQ-funded research into practice and policy, grantees are to
inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when
articles from their AHRQ-supported activities are accepted for publication in
the professional literature. Grantees should also discuss any ideas about
other dissemination and marketing efforts with OCKT staff. The goal is to
ensure that efforts to disseminate research findings are coordinated with other
Agency activities to maximize awareness and application of the research by
potential users, including clinicians, patients, health care systems and
purchasers and policymakers. This is critical when outreach to the
general and trade press is involved. Accordingly, contact with the media
will take place with close coordination between OCKT and the press offices of
the grantee's institutions. In cases when products are created (such as
annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to
submit to OCKT a brief plan describing how the product will be
publicized. An OCKT staff person will be assigned to each product and
will coordinate the implementation of the plan, especially issues related to
printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs,
AHRQ may request information essential to an assessment of the effectiveness of
Agency research programs. Accordingly, grant recipients are hereby
notified that they may be contacted after the completion of awards for periodic
updates on publications resulting from AHRQ grant awards, and other information
helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed
of publications, as well as the known uses and impact of their Agency-sponsored
research. Applicants must agree to notify AHRQ immediately when a manuscript
based on research supported by the grant is accepted for publication, and to
provide the expected date of publication as soon as it is known, regardless of
whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of
AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical
Expenditure Panel Survey (MEPS). HCUP is a family of health care
databases and related software tools and products developed through a
Federal-State-Industry partnership. HCUP databases bring together the
data collection efforts of State data organizations, hospital associations,
private data organizations, and the Federal government to create a national
information resource of patient-level health care data. HCUP databases
provide data beginning in 1988 and contain encounter-level information for all
payers compiled in a uniform format with privacy protections in place.
HCUP include two nationwide databases, the Nationwide Inpatient Sample (NIS)
and the Kids’ Inpatient Database (KID), and three types of State
databases, the State Inpatient Databases (SID), the State Ambulatory Surgery
Databases (SASD), and the State Emergency Department Databases (SEDD).
More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally
representative estimates of health care use, expenditures, sources of payment,
and insurance coverage for the U.S. civilian, non-institutionalized
population. MEPS is composed of three component surveys: the Household
Component (HC), the Medical Provider Component (MPC), and the Insurance
Component (IC). The Household Component is the core survey, and it
forms the basis for the MPC sample and part of the IC sample. The MEPS IC
collects data on health insurance plans obtained through employers and unions,
including the number and types of private insurance plans offered, employer
characteristics, prmeiums, and contributions by employers and employees.
More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants’ use of HCUP and/or MEPS data does not
preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

Within the
network research data must be shared. The precise content of the data-sharing
plan will vary, depending on the data being collected. For external data sharing
applicants may wish to describe briefly the expected schedule for data sharing;
the format of the final dataset; the documentation to be provided; whether or
not any analytic tools also will be provided; whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use); and the mode of data sharing
(e.g., under its own auspices by mailing a disk or posting data on its
institutional or personal website or through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.

The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.

Section V. Application Review Information

1.
Criteria

Administrative Criteria: Upon receipt, applications
will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria are described below.
The review criteria described below will be considered in the review
process.

2. Review and
Selection Process

Applications that are complete and responsive to the FOA will be evaluated for
scientific and technical merit by an appropriate peer review group convened in
accordance with standard AHRQ peer review procedures that are described in 42
CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or
applications not following instructions given in this FOA will not be reviewed.

As part of the initial merit review, all applications
will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit will be discussed
and assigned a priority score

Receive a written critique

In their written critiques, reviewers will be asked to
comment on each of the following criteria in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit of these
goals. Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application.

Significance

Approach

Innovation

Investigators

Environment

Collaborative
Research Experience

Patient
Resources

Stakeholder
Involvement

Note that an application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus deserve
a meritorious priority score. For example, an investigator may propose to carry
out important work that by its nature is not innovative but is essential to
move a field forward.

Significance: Do the registry and studies address an important problem?
If the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Approach: Are
the clinical registry framework, design, methods, and analyses adequately
developed, well-integrated, well-reasoned, and appropriate to the aims of the
registry? Does the applicant acknowledge potential problem areas and consider
alternative tactics?

Innovation:
Is the registry project original and innovative? For example: Do studies
challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Do studies develop or
employ novel concepts, approaches or methodologies, tools, or technologies for
this area?

Investigators: Are key personnel appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience
level(s) of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the registry project?

Environment: Do(es) the scientific and administrative environment(s) in
which the work will be done contribute to the probability of success? Do the
proposed studies benefit from unique features of the scientific environment(s),
or subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support? Are institutional resources adequate for patient care and
follow-up: including personnel, space, and special facilities?

Collaborative
Research Experience: Is there evidence of a willingness and ability to
participate fully in all studies and to adopt and follow standard operating
procedures? Is there evidence from past experience of an ability to conduct
rigorously designed trials including a clinically relevant and testable
hypothesis, well described patient population, explicit selection criteria, and
effective control of bias? Has the applicant shown a willingness and
ability to establish collaborations with appropriate clinical specialists for
conducting trials that bridge both the surgical and medical therapies in
relation to the proposed studies?

Patient
Resources: Are
the plans to recruit, enroll, and retain study populations adequate for the
proposed studies? Does the application demonstrate that there are sufficient
patient resources to participate in the registry?

Stakeholder Involvement: Has
the application demonstrated that the project is applicable to problems
important to stakeholders? Does the application describe a plan to
involve key stakeholders in the research? Stakeholders may include, for
example, decision makers such as the relevant policy makers of the subject
matters (e.g., CMS, FDA) and patients. This evidence may include specific
and detailed plans to solicit stakeholder input during the registry development
and research process.

2.A. Additional Review
Criteria:

In addition to the above criteria,
the following items will be considered in the determination of scientific merit
and the priority score:

Degree of responsiveness: How
well does the application address the purpose and objectives of this FOA?
How responsive is the application to the special eligibility criteria,
including the project requirements, noted in the FOA?

Budget: Is the proposed budget reasonable and is the
requested period of support appropriate in relation to the proposed research?

Protection of Human Subjects
from Research Risk: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. See Part II,
Section 5.1 “Protection of Human Subjects” of the PHS398
application instructions.

Privacy and Security Protections for Patients:
The resources and processes to be used to address privacy and security issues
in the development and implementation of the intervention will be assessed.

Applications submitted in response to this funding
opportunity will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as
determined by peer review

Availability of funds

Responsiveness to goals and objectives of the FOA

Relevance to program priorities

Programmatic balance

Portfolio balance within AHRQ and DHHS

2.B. Additional Review Considerations

Not Applicable

2.C. Resource Sharing
Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the
course of any AHRQ supported-study that identifies an individual or entity must
be treated as confidential in accordance with any explicit or implicit promises
made regarding the possible uses and disclosures of such data. There are
civil monetary penalties for violation of the confidentiality provision of the
AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the
application, applicants must describe procedures for ensuring the
confidentiality of the identifying information to be collected. The
description of the procedures should include a discussion of who will be
permitted access to this information, both raw data and machine readable files,
and how personal identifiers and other identifying or identifiable data will be
restricted and safeguarded. Identifiable patient health information
collected by grantees under this FOA will also be obtained and managed in
accordance with 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by
the Department of Health and Human Services (DHHS) pursuant to the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). These
regulations serve to limit the disclosure of personally identifiable patient
information by covered entities and define when and how such information can be
disclosed e.g., to researchers. Thus, health care plans ordinarily will
require either patient authorization for disclosures of identifiable
information to be made to researchers or waivers of such authorizations
obtained from an IRB or Privacy Board (defined in the regulations), which will
involve review to ensure that identifiable health information will be
appropriately safeguarded by the investigators. The DHHS Office of Civil
Rights is the enforcement body for this regulation. Additional information
about the regulations, their implementation, and alternative methods of
permissible disclosures to researchers (limited data sets with data use
agreements, de-identified data sets, data about deceased persons, and data use
to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems
containing confidential data have a level and scope of security that equals or
exceeds that established by the HIPAA Security Rules if applicable (see HIPAA
website in prior paragraph) and that established by the Office of Management
and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal
Automated Information Systems. The National Institute of Standards and
Technology (NIST) has published several implementation guides for this
circular. They are: An Introduction to Computer Security: The NIST Handbook;
Generally Accepted Principals and Practices for Securing Information Technology
Systems; and Guide for Developing Security Plans for Information Technology
Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/.
The applicability and intended means of applying these confidentiality and
security standards to subcontractors and vendors, if any, should be addressed
in the application.

Sharing Research Resources:

Rights
in Data

AHRQ grantees may copyright, unless otherwise provided in
grant awards, or seek patents for, as appropriate, final and interim products
and materials developed in whole or in part with AHRQ funds, including, but not
limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are
subject to a worldwide irrevocable AHRQ license to use and permit others to use
these products and materials for government purposes. In accordance with
its legislative dissemination mandate, AHRQ purposes may include, subject to statutory
confidentiality protections, making project materials, databases, results, and
algorithms available for verification or replication by other
researchers. In addition, subject to AHRQ budget constraints, final
products may be made available to the health care community and the public by
AHRQ or its agents if such distribution would significantly increase access to
a product and thereby produce substantial or valuable public health
benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research
findings but relies on grantees to publish research results in peer-reviewed
journals and to market grant-supported products. AHRQ's Office of
Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance
of publication in order to coordinate announcements of new AHRQ-supported
research results with other AHRQ dissemination activities. Important
legal rights and requirements applicable to AHRQ grantees are set out or
referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available
in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via theeRA Commons.

If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NoA) will be provided to
the applicant organization. The NoA will be generated via email
notification from the awarding component to the grantee business
official. The NoA, signed by the grants management officer, is the
authorizing document.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of
the NOA are at the recipient’s risk. These costs may be reimbursed
only to the extent considered allowable pre-award costs. See also Section
IV.5., “Funding Restrictions.”

2.
Administrative and National Policy Requirements

All
AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants
regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements
of the HHS Grants Policy Statement that are applicable based on the recipient
type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As
necessary, special Terms and Conditions will be incorporated into the award
statement.

The annual progress report must include Sections a
through f as described in the general PHS form 2590 instructions. For details regarding progress report
submission, refer to http://www.ahrq.gov/fund/noncomp.htm.
If instructions on the AHRQ website are different from the PHS form 2590
instructions, follow the instructions on the AHRQ website.

The progress report is to include descriptive and
evaluative comments on both completed activities and plans for the remainder of
that year, including any changes foreseen in the future. At a minimum,
the reports will include descriptive comments on: progress to date
measured against project aims; methodological changes implemented; key
preliminary findings; significant problems and resolutions; inclusion of
priority populations; and project related publications, presentations, and
dissemination activities.

Financial
Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant
programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).
This report must be submitted for each budget period no later than 90 days
after the close of the budget period. A hard copy of the report should be
submitted to the AHRQ FSR coordinator.

A final Progress Report, Final Financial Status Report
and Final Invention Statement are required when an award ends. For
further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency
Contacts

We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may be written or by telephone,
and fall into three areas: scientific/research (program), peer review, and
financial or grants management issues.

1.
Scientific/Research Contacts:

Direct your questions about general FOA issues, including information on
the inclusion of priority populations to:

Women and members of minority groups are included in all
AHRQ-supported research projects involving human subjects, unless a clear and
compelling rationale and justification are provided that inclusion is
inappropriate, e.g., because of the lack of connection between the study and
the health of women or particular minorities.

Investigators may obtain copies from the above sources or
from the NIH Guide Web site at https://grants.nih.gov/grants/guide/index.html.
AHRQ Program staff may also provide additional information concerning
these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that
applications and proposals involving human subjects research must be evaluated
in accordance with those regulations, with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

The Department of Health and Human Services (DHHS)
"Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 which governs the protection of individually
identifiable health information. It is administered and enforced by the
DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools that may be used to determine whether a researcher is a staff
member of a covered entity. Compliance with the Privacy Rule for those
classified under the Rule as "covered entities" is mandatory.
Decisions about applicability and implementation of the Privacy Rule
reside with covered entities. Project Officers will assist grantees in
resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access
to research data developed with Federal support through the Freedom of Information Act (FOIA) in certain circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
If no Federal action is taken having the force and effect of law in reliance
upon an AHRQ-supported research project, the underlying data are not subject to
this disclosure requirement. Furthermore, even if a Federal regulatory
action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC
552(b), disclosure of confidential identifiable data from such study is
statutorily protected under 42 USC 299c-3(c), and thus is exempted from
disclosure under "the (b)(3) exemption” in FOIA, 5 USC
552(b)(3). It is important for applicants to understand the scope of this
requirement and its limited potential impact on data collected with AHRQ
support. Proprietary data might also be exempted from FOIA disclosure
requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for
example, if it constitutes trade secrets or commercial information. NIH
has provided general related guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
which does not include discussion of the exception applicable to confidential
identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this
FOA in a public archive, which can provide protections for the data (e.g., as
required by confidentiality provisions of the statute applicable to
AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of
non-identifiable data for an indefinite period of time, they may. The
application should include a description of any archiving plan in the study
design and include information about this in the budget justification section of
the application. In addition, applicants should consider how to structure
informed consent statements or other human subject protection procedures to
permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting health improvement
priorities for the United States. AHRQ encourages applicants to submit grant
applications with relevance to the specific objectives of this initiative.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in
accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes
and regulations. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the Public Health Service mission to protect and advance the physical and
mental health of the American people.